Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality

NCT06600633 | Recruiting

• 2 other identifiers: KEP-4-6/2024-AL7-50044
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

single-center, randomized, cross over, double-blind, placebo controlled intervention study

Conditions

Sleep Onset Latency; Sleep Quality

Keywords

melatonin; supplementation; sleep; sleep onset latency; actigraphy; sleep quality; sleep efficiency

Outcome Measures

Primary Outcomes (1)

• Change in sleep onset latency (SOL) compared to placebo

  Change in sleep onset latency (SOL) compared to placebo assessed by actigraphy.

  last 7 days of intervention

Secondary Outcomes (2)

• Changed sleep quality compared to placebo

  14 days

• Changed sleep efficiency (SE) compared to placebo

  last 7 days of intervention

Study Arms (3)

Placebo product (PP)

PLACEBO COMPARATOR

Active ingredient: none Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.

Dietary Supplement: 14 days of intervention with Placebo Product (PP)

Active control (AC)

ACTIVE COMPARATOR

Active ingredient: 1 mg of melatonin per dosage Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.

Dietary Supplement: 14 days of intervention with Active Control (AC)

Test product (TP)

EXPERIMENTAL

Active ingredient: 0.3 mg of melatonin per dossage Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.

Dietary Supplement: 14 days of intervention with Test Product (TP)

Interventions

14 days of intervention with Placebo Product (PP) DIETARY_SUPPLEMENT

1 spray (0 mg melatonin)

Placebo product (PP)

14 days of intervention with Active Control (AC) DIETARY_SUPPLEMENT

1 spray (1 mg melatonin)

Active control (AC)

14 days of intervention with Test Product (TP) DIETARY_SUPPLEMENT

1 spray (0.3 mg melatonin)

Test product (TP)

Eligibility Criteria

• Age: 24 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subject Informed consent form (ICF) is signed
• aged 24-65 years at the time of the signature of ICF
• suboptimal sleep quality according to Pittsburgh Sleep Quality Index (PSQI-SI): PSQI higher than 5
• no clinically significant (subthreshold) insomnia according to Pittsburgh Sleep Quality Index (PSQI-SI) (Kmetec et al., 2022): PSQI up to 9
• a body mass index (BMI) up to 32 kg/m2
• stable medications for non excluded concurrent medical conditions for six weeks prior to the screening visit
• ability to ingest oral food supplement (study product)
• willing to follow all study procedures, including attending all site visits and use of actigraphy

You may not qualify if:

• diagnosed or subject to therapy due to sleep disorders
• acute infectious disease
• any kind of chronic pharmacological therapy with antihypertensives or antidepressants
• any kind of other pharmacological therapy that could interact with active ingredients used in the study
• pregnancy or planned pregnancy, lactation, menopause (with clinically relevant symptoms/therapy)
• use of beta-blockers
• chronic use of use of prostaglandin synthesis inhibitors (nonsteroidal anti-inflammatory drugs), such as acetylsalicylic acid and ibuprofen
• supplementation with melatonin or other food supplements intendent for sleep quality during last 2 weeks
• unwillingness to maintain caffeine abstinence after 4:00 PM during the study
• not having a mobile upper extremity for attaching an actigraph
• known alcohol and/or drug abuse
• unwillingness to comply with the maximum limit of 2 alcoholic drinks per day, and only up to 1 alcoholic drink after 6:00 PM during the study
• known lactose/gluten intolerances/food allergies
• known gastrointestinal disease
• less than 5 years after treatment for gastrointestinal cancer (stomach, duodenum or colon)

Sponsors & Collaborators

• Institute of Nutrition, Slovenia (Nutris): lead
• Faculty of Pharmacy, University of Ljubljana, Slovenia: collaborator
• Faculty of health sciences, Celje, Slovenia: collaborator
• CMS - Center za motnje spanja, Ljubljana, Slovenia: collaborator
• Valens Int. d.o.o., Slovenija: collaborator

Study Sites (1)

CMS - Center za motnje spanja

Ljubljana, 1000, Slovenia

RECRUITING

Related Links

• NutriSom project webpage: Efficacy and safety of dietary supplementation in targeting sleep quality (L7-50044)

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Igor Pravst

  Nutrition Institute, Ljubljana

  STUDY CHAIR

• Barbara Gnidovec Stražišar

  Faculty of Health Sciences in Celje, CMS - Center za motnje spanja

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Igor Pravst, PhD

CONTACT

+386 590 68871; igor.pravst@nutris.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Igor Pravst

Model Details: Three-period crossover study will include 30 subjects who will test three formulations with diferent melatonin dosages (placebo product without melatonin, and two products with different melatonin levels). Subjects will have 2 week intervention with each of the tested formulations with 2 week wash-out.

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: September 17, 2024
• Primary Completion: September 17, 2025
• Study Completion: September 17, 2025
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

SL (1)